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For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.

VK-3 Verification Kit is a calibration verification kit consisting of the following 5 quality control solutions: Hematocrit and Metabolite QUALICHECK Level 1, S7170 (K150226), Hematocrit and Metabolite QUALICHECK Level 2, S7180 (K150226), Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236). These quality control solutions have been 510(k) cleared (K150226 and K130236) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Hematocrit and Metabolite QUALICHECK quality control solutions are aqueous solutions containing organic buffer, acid, salts, metabolites, and a preservative. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen. VK-4 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Qualicheck 5+ Level 1, S7730 (K980135), Qualicheck 5+ Level 2, S7740 (K980135), Qualicheck 5+ Level 3, S7750 (K980135), Qualicheck 5+ Level 4, S7760 (K980135). These quality control solutions have been 510(k) cleared (K980135) with an intended use which did not include calibration verification. Production of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen. VK-R5 Verification Kit is a calibration kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), Qualicheck 5+, Level 3, S7750, (K980135). These quality control solutions have been 510(k) cleared (K130236 and K980135) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen. VK-R7 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), High Metabolite QUALICHECK Level 1, S7570 (K130415). These quality control solutions have been 510(k) cleared (K130236 and K130415) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen. The High Metabolite QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, metabolites and a preservative. VK-Crea Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: AutoCheck6+ Level 1, S7835 (K051928), AutoCheck6+ Level 2, S7845 (K051928), AutoCheck6+ Level 3, S7855 (K051928), Cleaning Met II Solution, S8377 (K051968). These quality control solutions have been 510(k) cleared (K051928) and (K051968) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each level of AutoCheck6+ and one bottle of Cleaning Met II Solution. Each AutoCheck6+ ampoule contains 0.7 mL solution. The Cleaning Met II Solution contains 100 mL solution. The quality control solutions are aqueous solutions containing biological buffers, salts, metabolites, enzyme and a preservative. The AutoCheck6+ solutions also contain dyes and are equilibrated with carbon dioxide and oxygen.